Senior Manager, Regulatory Affairs - Permanent - Remote
Proclinical is seeking a Senior Manager, Regulatory Affairs - Ad/Promo to join a global pharmaceutical company. This is a permanent role with the opportunity to work remotely.
Primary Responsibilities
In this role, you will serve as a regulatory approver of all advertising and promotional materials for assigned product(s) and take an active role in supporting the submission of these materials to the FDA. You will develop and maintain current knowledge of requirements for US regulation of drug marketing and advertising and competitive landscape. In addition, you will collaborate with co-creation partners in the development of new promotional initiatives/programs and reviews supporting materials ensuring compliance with regulations. The position can be based at their Georgia site (preferred) or remote-based within the United States.
Skills & Requirements:
- At least 3 years of relevant experience in the pharmaceutical industry, with preferably 2 years in Regulatory Affairs and specific experience in US advertising and promotion material review and approval, and labeling. Basic knowledge of US labeling and promotion regulations and guidance.
- Knowledge of science and data of assigned products and how that translates into labeling language.
- Knowledge of competitive landscape and how other companies are dealing with similar issues in labeling and promotion.
- Must be eligible to work in the US.
The Senior Manager, Regulatory Affairs will:
- Supports complex OPDP submissions in collaboration with company contract support.
- Participates in and/or directs the regulatory review of non-promotional scientific information, and external communication materials, including media information and provides proactive feedback.
- Develop and maintain current knowledge of US regulation of labeling and industry standards for labeling and communicate requirements to other departments in a timely manner.
- Direct the labeling control process for tracking, implementation and regulatory submission of changes to existing labeling.
- Compilation of Labeling Review Committee (LRC) packages for all US labeling components.
If you are having difficulty in applying or if you have any questions, please contact Phu Huynh at (+1) 646-779-7961 or p.huynh@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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